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RecruitingNCT05655650SEEDSUpdated Sep 18, 2026

Identifying Biomarkers in Alzheimer's Disease

An observational study in Neuro-Degenerative Disease and Alzheimer Disease, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Chinese University of Hong Kong · Observational

From the registry’s dates

  • Started Sep 2018; still recruiting 8 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
20 Years and older
Sex
All
01

Study summary

Alzheimer's disease is a severe neurodegenerative disorder of the brain that is characterized by progressive loss of memory and cognitive decline. With the ageing population, AD is a major public health problem affecting nearly 35 million people worldwide with numbers projected to rise to 115.4 million by 2050. AD is the only cause of death among the top ten causes that has no prevention or cure . It is believed that novel treatment of AD needs to start early or even at the prodromal stage in order to be effective. Therefore, there is an urgent need to find accurate methods of early detection before patients with AD develop clinical dementia.

This study aims to identify biomarkers for AD in local Chinese population. this study hypothesizes blood-based proteomics, retinal imaging, ASL-MRP and tau PET can improve the accuracy and staging of AD.

Read the detailed description

This is a cohort study. It involves baseline and 6 yearly follow ups. At baseline, all participants will go through a list of cognitive assessments, blood taking, Brain MRI scan, Brain PET scan and retinal imaging.

At the first five yearly follow ups, cognitive assessment will be performed. For the sixth yearly follow up, automatic retinal image will be performed in addition to cognitive assessment.

02

Conditions studied

  • Neuro-Degenerative Disease
  • Alzheimer Disease

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Keywords

  • Alzheimer Disease
03

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

AD subjects will be recruited from neurology cognitive disorder clinic of Prince of Wales Hospital. Age match normal control will be recruited from existing normal control studies.

Inclusion criteria

  • Chinese ethnicity
  • [For dementia group, clinical diagnosis of "probable Alzheimer's disease" according to recommendation from the National Institute on Aging-Alzheimer's Association workgroups (NIA-AA)

Exclusion criteria

Exclusion Criteria:

  • Clinical diagnosis of non-AD dementia
  • contraindication for MRI or PET
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Normal cognition

    75 subject without any of the following: subjective memory complaint and cognitive impairment base on cognitive assessments

  • Subjective Cognitive Disorder

    75 subjects without cognitive impairment based on cognitive cognitive assessments but with subject memory complaint

  • Mild Cognitive Impairment

    75 subjects with both subjective memory complaints and mild cognitive impairment base on cognitive assessments

  • Dementia

    75 subjects with both subjective memory complaints and moderate to severe cognitive impairment base on cognitive assessments

06

What researchers measure

Primary outcomes

  1. The score change in Hong Kong List Learn Test (HKLLT)

    The Hong Kong List Learn Test would be administered to assess the cognitive status for all group of study subjects

    Time frame: Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit

  2. The score change in Montreal Cognitive Assessment Hong Kong (HK-MoCA)

    The Montreal Cognitive Assessment Hong Kong would be administered to assess the cognitive status for all group of study subjects

    Time frame: Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit

  3. The score change Clinical Dementia Rating (CDR)

    The Clinical Dementia Rating would be administered to assess the cognitive status for all group of study subjects

    Time frame: Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit

  4. Amount of amyloid β with 11C-Pittsburgh compound B

    Positron emission tomography imaging with 11C-Pittsburgh compound B would quantify the amount of amyloid β. Amyloid β is one of the biomarkers associate Alzheimer Disease

    Time frame: Baseline

  5. Amount of amyloid tau with T807 tracer

    Positron emission tomography imaging with T807 tracer would quantify the amount of tau protein. tau protein is one of the biomarkers associate with Alzheimer Disease

    Time frame: Baseline

  6. Amount of glucose hypometabolism

    Positron emission tomography imaging with 18F-FDG tracer would quantify the amount of glucose hypometabolism. glucose hypometabolism is one of the biomarkers associate with Alzheimer Disease

    Time frame: Baseline

  7. arterial spin labeling magnetic resonance perfusion (ASL-MRP)

    Arterial spin labeling (ASL) perfusion is a MRI technique to quantify tissue blood flow of all group of subjects

    Time frame: Baseline

  8. Change of Automatic Retinal Imaging

    There is a close anatomical correlation between both the macrovascular and the microvascular blood supply to the brain and the retina, and both vascular networks share similar vascular regulatory processes. Automatic Retinal Imaging is used to investigate microcirculations in retinal

    Time frame: Baseline, 6th year follow up

07

Study locations

1 of 1 sites recruiting
  • Chinese University of Hong Kong
    Hong Kong, Hong Hong, Hong Kong
    • Elyia Han, Bachelor · Contact · elyiahan@cuhk.edu.hk · +852 26975027
    • Vincent Mok, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05655650
Lead sponsor
Chinese University of Hong Kong
Responsible party
Vincent Mok (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Dec 19, 2022
Start date
Sep 1, 2018
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 18, 2026

Study contacts

Pualine Kwan
Contact
paulinekwan@cuhk.edu.hk
+852 26352160
Elyia Han
Contact
elyiahan@cuhk.edu.hk
+852 2697 5027

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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